RedHill Biopharma licenses RHB-102 for global commercialization to Hyloris

RedHill Biopharma (RDHL) has entered into an exclusive worldwide development and commercialization licensing agreement, excluding North America, with Hyloris Pharmaceuticals for RedHill’s RHB-102. Hyloris will pay RedHill an upfront payment, in addition to up to $60M in potential milestone payments, contingent upon achieving specified commercial targets, plus up to mid-20s percent royalties on revenues, subject to certain cost recoupments, with minimum annual payments to RedHill, in return for exclusive rights to RHB-102 across all indications and territories outside the U.S., Canada and Mexico. RedHill intends to continue development of RHB-102 for FDA approval in the U.S., if granted. Hyloris will be responsible for all development, regulatory and commercialization activities related to RHB-102 in its territories. Recent positive advice from the UK’s MHRA provided a clear pathway for a UK Marketing Authorization Application for RHB-102 for oncology support in the UK, and potentially in other countries, subject to completion of certain manufacturing activities. If approved, RHB-102 could be the first oral 24-hour extended-release ondansetron antiemetic drug for the treatment of chemotherapy/radiotherapy-induced nausea and vomiting.